GB 17168-2013Dentistry -- Metallic materials for fixed and removable restorations and appliances (English PDF)

5.1 Chemical composition

5.1.1 Marked components

The manufacturer shall declare all ingredients content greater than 1.0% (mass fraction) [see 9.1a)], accurate to 0.1% (mass fraction).

The content is not more than 1.0% (mass fraction) but greater than 0.1% (mass fraction) of the component shall be marked with the name or symbol [see

9.1a)].

5.1.2 Statement content of each component tolerances

For silver-based or a noble metal alloy, alloy percentage of each ingredient and packaging, label or interstitial marked deviation value is not greater than

0.5% (mass fraction) [see 9.1a)].

Content of each component for non-precious alloys, the content of more than 20% (by mass) of the packaging, labeling or insert within the indicated value

Deviation is less than 2.0% (mass fraction). Content higher than 1.0% (mass fraction) but not more than 20% (mass fraction) of each ingredient hundred

Content of the packaging, label or interstitial marked deviation value is not more than 1.0% (mass fraction) [see 9.1a)].

5.2 harmful ingredients

5.2.1 recognized harmful ingredients

According to this standard uses, nickel, cadmium and beryllium specified as harmful ingredients.

5.2.2 limit values of harmful components cadmium and beryllium

Content of cadmium or beryllium metal material is not more than 0.02% (mass fraction).

5.2.3 manufacturers label their nickel content Tolerance

If the metal material nickel content greater than 0.1% (mass fraction), should be in the package [see 9.1n)] accompanying documents and packaging, labeling

Or interstitial [see 10.2f)] mark on this content and accuracy of 0.1% (mass fraction).

The mass fraction of nickel content should not exceed 9.1n) and 10.2f) specified value.

5.3 biocompatibility

Biocompatible see the introduction guide.

5.4 Mechanical properties

5.4.1 Overview

8.3.2 shall be tested.

After the recommended processing (for example. casting, air-cooled, machining), and after porcelain bake metallic material (if applicable) should be consistent

Table 1 requirements. Recommended with or without ceramic finishes metal material in both metallurgical state should meet the requirements.

If the manufacturer recommended heat treatment [9.2c)], the manufacturer's instructions when used in accordance with the material under heat treatment conditions should

Compliance with this requirement.

If the metal material is suitable for metallurgical state of more than one (by one of the production process), it might have a different classification (according to

Table 1), it should provide the highest type of use in each condition of use.

Table 1 Mechanical properties of metallic materials

Types of

0.2% non-proportional extension

Strength Rp0.2/MPa

Least

The Elongation /%

Least

Young's modulus/GPa

Least

5.4.2.1 compliance determination

Reference 9.lb) Category type specified.

If the six samples tested in the first group there are four, five or six meet the 0.2% non-proportional extension strength requirements, it is considered

The metal material to meet the requirements.

If the six samples tested in the first group there are two or fewer samples meet the 0.2% non-proportional extension strength requirements, it is considered

The metal material does not meet the requirements.

Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can replace the first set with a second set of samples

The part of the sample. The first two sets of the remaining sample as a sample group of the second trial.

Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means reached the completion of the first test group

The number of specimens required six requirements (ie, including the replacement of the total number of sample specimens).

If the six samples tested in the first group there are three or four samples according to 8.3.2 is discarded, and replaced with a second set of samples, then 12

Samples are to be tested. At least eight of the sample results in line with 0.2% of non-proportional extension strength requirements in order that the metal sheet

Expected to meet the requirements.

If the six samples tested in the first group there are three samples meet the 0.2% non-proportional extension strength requirements, then the first two sets of the remaining

All samples should be tested. If the second test group has five or six samples in line with 0.2% of non-proportional extension strength requirements, is recognized

For metallic materials meet the requirements.

Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), and a sample with a second set of alternatives that

What of the second set all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples.

If the six samples tested in the first group there are three samples meet the 0.2% non-proportional extension strength requirements and test group 2

There are four or fewer samples meet the 0.2% non-proportional extension strength requirements, it is considered that the metal material does not meet the requirements.

5.4.2.2 mean

0.2% non-proportional extension strength of the average of the accompanying documentation and packaging [see 9.1c)] as shown in the deviation value should not exceed 10%.

5.4.3 percentage elongation after fracture

5.4.3.1 compliance determination

Reference 9.1b) Category type specified.

If the six samples tested in the first group in line with 0.2% of non-proportional extension strength requirements of four, five or six samples in line with

Requirements of the Elongation of the metal material is considered to meet the requirements of the Elongation of.

If the six samples tested in the first group there are two or fewer samples to meet the requirements of the Elongation, it is believed that the metal material is not

Meet the requirements of the Elongation of.

Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can use the first two sets of the first set of alternate sample

The part of the sample. The first two sets of the remaining samples constituting the second test group.

Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means that the first group completed the trial test

The number of specimens is 6 (ie, the total number of samples included in the sample alternative).

If the six samples tested in the first group there are three or four samples according to 8.3.2 is discarded, and replaced with a second set of samples, then 12

Samples are to be tested. If they meet the 0.2% non-proportional extension strength required at least eight samples are also consistent with the Elongation of

Requirements, the metal material is considered to meet the requirements of the Elongation of.

If the six samples tested in the first group in line with 0.2% of non-proportional extension strength requirements of the three samples is also consistent with the Elongation

Requirements, then the rest of the second set of all samples should be tested. If the second test group of five or six samples comply Elongation

Rate and 0.2% non-proportional extension strength requirements, the metal material is considered to meet the requirements of the Elongation of. If the second test group

The five or six samples meet the requirements of the Elongation, but does not meet the 0.2% non-proportional extension strength requirements, it is considered the gold

Metallic material does not meet the requirements of the Elongation of.

Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), and a sample with a second set of alternatives that

What of the second set all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples.

If the six samples tested in the first group there are three samples meet the requirements of the Elongation, and Group 2 Test 4 or more

Less consistent with the Elongation of the sample requirements, that the metal material does not meet the requirements of the Elongation of.

5.4.3.2 mean

The average percentage elongation after fracture should be greater than shown in the accompanying documentation package value of 70%, but not less than the minimum value of the type [see

9.1d)].

5.4.4 Young's modulus

5.4.4.1 5 type material compliance determination reference 9.1b) specified category type.

If the six samples tested in the first group, in line with 0.2% of non-proportional extension strength and elongation after fracture required four, five or

6 samples in line with the requirements of the Young's modulus, it is considered that the metal material meets the requirements of the Young's modulus.

If the six samples tested in the first group, there are two or fewer samples meet the 0.2% non-proportional extension strength and elongation after fracture

Requirements, even if they meet the requirements of the Young's modulus, but also that the metallic material does not meet the requirements of the Young's modulus.

Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can use the first two sets of the first set of alternate sample

The part of the sample. The first two sets of the remaining samples constituting the second test group.

Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means that the first group completed the trial test

The number of specimens is 6 (ie, the total number of samples included in the sample alternative).

If the six samples tested in the first group there are three or four samples according to 8.3.2 are discarded, while the second set of samples with replacement, then 12

Samples are to be tested. If it meets the 0.2% non-proportional extension strength, and at least eight samples of the Elongation requirements are in compliance

Young's modulus of the requirements, the metal material is considered to meet the requirements.

If the six samples tested in the first group, in line with 0.2% of non-proportional extension strength and elongation after fracture required three samples also breaks

Closing the Elongation requirements, then the remaining 2 sets all samples should be tested. If the second test group of five or six samples were

In line with Young's modulus, 0.2% of the requirements of non-proportional extension strength and elongation after fracture, the metal material is considered to be in line with Young's modulus

Demand; otherwise, the metal material that does not comply with the requirements of the Young's modulus.

Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), a sample replacement by the first two sets, then

2 sets all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples.

5.4.4.2 mean

Deviation values shown on the Young's modulus of the average value of the package accompanying document should not exceed ± 10% [see 9.1e)].

5.5 Density

Deviation values shown in the accompanying documentation and packaging density metallic materials should not exceed ± 5% [see 9.1f)].

5.6 corrosion resistance

8.5 when tested in accordance with the metal material at (37 ± 1) °C, (7.0 ± 0.1) d is released within the specified solution (see 8.5.4) total

Metal ions should not exceed 200µg/cm2.

Metallic materials using the recommended processing techniques (for example. casting, air-cooled, machining) and after the sintering procedures (if applicable) should be

Meet the above requirements. Recommended for use with or without ceramic finishes metal material in both metallurgical state should meet this requirement.

5.7 tarnish

Packaging accompanying document "information", the statement has "tarnish resistance" product for this requirement.

Exposure to the specified dark environment (see 8.6), if only very slight color change, and by gently brushing can be easily removed

Rust on the alloy composition, in the accompanying documents package can be described as "anti tarnish" [see 9.1g)].

After the recommended processing (for example. casting, air-cooled, machining), and after porcelain bake metallic material (if applicable) should be consistent

The above-mentioned requirements. Recommended with or without ceramic finishes metal material in both metallurgical state should meet this requirement.

5.8 solidus and liquidus temperature (alloys) or melting point (commercially pure metal)

For the solidus temperature of the alloy is less than or equal to 1200 °C, as shown on the accompanying documents solidus and liquidus temperature and packaging value

The deviation should be no greater than ± 20 °C [see 9.1h)].

For the alloy solidus temperature greater than 1200 °C, the deviation value shown on the accompanying documents solidus and liquidus temperature and packaging

Should not exceed ± 50 °C [see 9.1h)].

For the melting point of less than or equal to 1200 °C commercial pure metal, the melting point of the deviation should not exceed ± 20 °C; a melting point greater than

Business 1200 °C of pure metal, the melting point of the deviation should not exceed ± 50 °C.

5.9 coefficient of linear expansion

This requirement only applies to metal - ceramic restorations with a metallic material.

Deviation values shown on the accompanying documents and the linear expansion coefficient of metal packaging materials should be less than 0.5 × 10-6K-1 [see 9.1i)].

Note. The linear expansion coefficient measured value with the manufacturer should be used for quality control values are consistent. Meet this requirement does not guarantee any particular alloy and the ceramic phase

match.

5.10 Information, descriptions and identification

All the requirements in Chapter 9 and Chapter 10 provisions should be properly introduced. If you need detailed description or recommendation, these instructions

And recommendations should be sufficient to achieve its purpose.

7.1 Overview

In accordance with the manufacturer's instructions (see 9.2) to prepare all samples.

If the sample is casting sprue should be carefully separated and removed all the tumor and casting burrs.

Replace all existing visual defects of samples.

7.2 Heat Treatment

7.2.1 Overview

In the metallurgical state in line with the intended use of sample testing of metallic materials for compliance.

7.2.2 the manufacturer's recommended instructions for use of heat-treating metal material

If the manufacturer recommended heat treatment [see 9.2c)], should be at the manufacturer specified in the instructions of the heat treatment conditions

deal with.

7.2.3 metal - ceramic prosthesis with a metal material

In the simulation test program after the following porcelain.

Under simulated porcelain powder recommended maximum melting temperature of the oxidation process and attached four porcelain program [see 9.1k)]. Each ceramic oxide and si...

END: Draft Version (GB 17168-2013)